MvPIFocusGroupsforMDAEreportingThefollowinggroupsplayasignificantroleinthesmoothfunctioningofMvPI:MedicalDeviceAdverseEventMonitoringCentres(MDMCs)andAdverseDrugReactionsMonitoringCentres(AMCs)Healthcarefacilities,includingdistrict/government/privatehospitals,andautonomousbodiesarerecognizedasMDMCsandAMCsbytheNCC-MvPI,IPCandNCC-PvPI,IPCrespectively.ThefunctionoftheMDMCistoraiseawarenessabouttheprogrammeandreportingofMDAEs.TheMvPIcollectsreportsfromtheMDMCs,AMCs.UndertheMvPI,50MDMCshavebeenidentifiedsofarinIndiatocollectthereportoftheeventsassociatedwiththeuseofmedicaldevices[6].TheAMCsestablishedunderthePharmacovigilanceProgrammeofIndia(PvPI)arealsoparticipatinginMDAEreporting.Around311centreshavebeenidentifiedinthecountrytoreporttheadverseeventsresultingfromtheuseofdrugs/medicalproducts[7].
ModalitiesforMDAEreportingTheNCCforMvPI,IPChasdevelopedthebelow-mentionedreportingtoolstocollectMDAEs.AllthereportingtoolsareavailableontheIPCwebsite.Thehealthcareprofessionals,MAHsandallthePersonalProtectiveEquipments(PPEs)usersareencouragedtoreportadverseeventsassociatedwithmedicaldevices[11].
MDAEreportingformTheMDAEreportingformprimarilyaimstocollecttheadverseeventsassociatedwiththeuseofmedicaldevices,In-VitroDiagnostics(IVDs),andmedicalequipments.Thehealthcareprofessionalsandothersincluding,butnotlimitedto,manufacturers,importers,distributors,andhospitalmanagersaresolicitedtoreporttheadverseeventsforknown,unknown,serious,non-serious,frequentorrareadverseevents.TheMDAEreportingformassemblesadverseeventinformationassociatedwithmedicaldevicesandconsistsofthefollowingninesections(Figure1)[11].
GeneralinformationThissectionincludesthedateofreport,i.e.thedateinwhichthereportwasfilled,andthetypeofreportthatspecifieswhethertheeventisInitial/Follow-up/Final/Trend.Theinitialreportisthefirsteventnotificationreportwhichmayincludetheminimalrequiredinformation,forinstance.Deviceinformation,detailsofadverseeventandreporterdetails.Areportmaybemarkedasafollow-upreportwhenadditionalinformationisavailablefromthepreviouslyreportedevent.Thereportmaybesubmittedasafinalreportwhenalltheinformationassociatedwiththeeventisavailableandcollected.Ifthereporterisobservingasignificantnumberofsimilaradverseevents,thereportermaytickthetrendoption[12].ReporterdetailsThissectioncomprisesthetypeofreporter,alongwiththedetailsofthereporter,including.Name,address,contactnumberande-mailaddress.Areportermaybeamanufacturer,importer,distributor,healthcareprofessional,patient,orother.Theinformationprovidedinthissectioniskeptconfidentialandonlyutilisedforfurtherfollow-up.
DevicedescriptionThissectiondescribesthespecificdetailsofthesuspectedmedicaldevice:devicenameorthebrandnameusedformarketingofthedevice,manufacturingorimportfirmnameandaddress,theinformationoflocaldistributer,thelot/batchnumber,serialnumber,yearofmanufacturing.Furthermore,incaseofmedicalequipment,theadditionalinformationalsoincludesinstallationdate,lastcalibrationdateandpreventivemaintenancedate,andsoftwareversionisalsoasked.Manycountriesusedifferentnomenclaturesystemsfornamingthemedicaldevice.ThemostprominentcodesknownaretheGlobalMedicalDeviceNomenclature(GMDN)andUniversalMedicalDeviceNomenclatureSystem(UMDNS).Inthereportingform,thereporterhasanoptiontoaddthenomenclaturecodeofthedevicewhilereportingtheevent.
Figure1.Pictorialrepresentationofmedicaldeviceadverseevent(MDAE)reportingform.
EventdescriptionThissectionincludesthemostimportantdatesassociatedwiththeadverseevent,suchasthedateinwhichtheeventoranynearmissincidentoccurred,etc.Furthermore,thissectionalsocomprisestheinformationaboutdeviceoperator,devicelocationandthedetaileddescriptionoftheevent.ThereportermaymarkaneventasseriousincaseitfulfilstheseriousnesscriteriadescribedinMDR2017[5].Otherwise,theeventmaybemarkedasnon-serious.
PatientinformationThissectioncontainsthepatientinformation,includingitsmedicalhistoryandfinalpatientoutcomeaftertheadverseeventhasoccurred.Additionally,thepatienthospitalID,age,genderisalsocomprisedinthissection.HealthcarefacilityinformationThissectionincludesthedetailsofthehospitalinwhichtheeventtookplace,aswellasthedetailsofacontactpersonatthehospital,forthefurtherfollow-upcommunicationrelatedtotheadverseevent.CausalityassessmentThissectionaimstocollecttheinformationregardingtheinvestigationprocesscarriedoutbytheclinicalspecialistsfromthehealthcarefacility,orbytheconcernedpersonnelfromthemanufacturingorganization,tofurtherdrawingouttherootcauseoftheproblemandtheimmediateactiontakentoreversetheadverseeffect,ifpossible.Therootcausewillascertainthemostlikelyreasonfortheoccurrenceoftheadverseevent.
Manufacturer/Authorizedrepresentativeinvestigation&actiontakenThissectionprovidestheinformationrelatedtotheinvestigationmethodsperformedbythemanufacturer/authorizedrepresentativeanddevicehistory,whichincludesareviewofsimilareventsoccurredfromthesamebatch/lot,theanalysisreportoftheeventrelatedtothemedicaldevice,andthecorrective/preventiveaction/recalltakentopreventthepatientfrombeingaffectedbythedevice,ifany.TheMDAEformisdesignedinsuchamannerthatitcollectsthemaximuminformationrequired,whichmaybehelpfulfortheidentificationoftheMDAEandforcreatingthedatabaseofthemedicaldevice-relatederrors,thusenablingtotracethetrendofadverseeventsassociatedwithmedicaldevices.TheMDAEformmayalsohelpthemedicaldevicestakeholderstoprovideappropriateinformationandenhancethequalityoftheinformationcollected.
Figure2.Pictorialrepresentationofpersonalprotectiveequipment(PPE)reportingform.
GeneralinformationThissectionincludestheexactdateinwhichtheeventwasreportedtotheNCC-MvPI,IPC,andthetypeofreportthatspecifieswhethertheeventisInitial/Follow-up.TheinitialreportisthefirstnotificationaboutanadverseeventsubmittedtotheNCC-MvPI,IPC,oncethereporterbecameawareofit.Thefollow-upreportcomprisestheadditionalinformationaboutthepreviousreport.
ReporterdetailsThissectioncomprisesthedetailsofthereporter,includingname,address,contactnumberande-mailaddress.Theinformationprovidedinthissectioniskeptconfidentialandonlyutilizedforthefollow-up.PPEtypeThissectionencompassesthetypeofPPEinvolvedintheadverseevent/reactiongloves,coverall,goggles,N-95masks,shoecovers,faceshields,bodybags,triplelayermedicalmask,amongothers.PPEdetailsThissectiondescribesthespecificdetailsofthePPEinvolvedintheadverseevent.Thesedetailsincludethebrandname,manufacturer/importer/distributername,batchnumber,modelnumber,licensenumber,uniquecertificationcode,teststandardfollowed,manufacturingdateandexpirydate.
LocationofeventThissectionreferstothelocationwheretheadverseeventhasoccurred,andincludesinpatientdepartment,quarantinefacilities,emergencydepartment,etc.TypeofeventThissectioncomprisestheseriousnessoftheevent.Iftheeventinvolvesthefollowingoutcomes:death/lifethreatening/disabilityorpermanentdamage/hospitalization/congenitalanomaly,thenitshouldbemarkedasserious.Otherwise,theeventmaybemarkedasnon-serious.UserdetailsThissectioncoversthedetailsofthePPEuser,includinguserinitials,age,gender,etc.
EventdescriptionThissectionincludesthedetaileddescriptionofanadverseeventassociatedwithPPEs.Hospital/quarantinefacilitydetailsThissectionprovidesthedetailsrelatedtothehospital/quarantinefacilities,includingname,addressandcontactperson.ThePPEformisdesignedinsuchamannerthatitcollectsalltherequiredinformation,whichmaybeusedfortheidentificationofPPE-relatedadverseeventsandforcreatingthedatabaseofsuchadverseevents.
Fieldsafetycorrectiveaction(FSCA)notificationformTheFSCA[11]referstoanyactiontakentoreduceariskofdeathorseriousdeteriorationinthestateofhealthassociatedwiththeuseofamedicaldevice,includingthe:(i)devicereturnedtothemanufacturer,(ii)devicedesignchanges,(iii)devicesoftwareupgrade,(iv)labellingchanges,(v)changesininstructionsforuseordirectionsforuseortechnicalmanual,(vi)devicedestructionand(vii)deviceexchange.Formoreinformation,see([13]).
LegalobligationThesubmittedMDAEreportdoesnothaveanylegalimplicationconcerningthereporters.Thepatients’identitywillbeheldunderstrictconfidenceandprotectedtoitsfullextent.Asthereportingprogrammeisvoluntaryinnature,healthcareprovidersareencouragedtoreportadverseeventsforabetterunderstandingoftheriskassociatedwiththeuseofmedicaldevices,andtosafeguardthehealthoftheIndianpopulation[14].EssentialdataforeffectivereportingThissectionincludesthefollowinginformation:dateofevent,reportercontactinformation,devicename,manufacturer/importer/distributordetails,cataloguenumber.,lot/batchnumber.,serialnumber.,modelnumber.,dateofimplantation/explantation(ifapplicable),seriousnessoftheevent,eventdescription,patienthistory,patientoutcome,healthcarefacilityinformation,rootcauseandcorrective/preventiveaction[13].
FactorscontributingtoaseriousadverseeventTheimproperfunctioningofthemedicaldevices,manufacturingdefects,designandlabellingissues,userandproceduralerrorsaresomeexamplesofthemajorcontributingfactorsthatcanleadtotheoccurrenceofaseriousadverseeventifunderestimated[15].
HelplinefacilityforreportingadverseeventsTheIPChasalreadylaunchedatoll-freehelplinefacility,helplineNumber-18001803024(MondaytoFriday-9:00amto5:30pm),forthereportingofadversedrugreactionsbyhealthcareprofessionalsandothers[16].Currently,thisfacilityisalsobeingextendedtothereportofanyadverseeventassociatedwiththeuseofmedicaldevices.Boththedatamanagementandtheprocedureadoptedtoreceivetheinformationfromthehealthcareprofessionals,patientsandothersaregiveninFigure3.
Figure3.Flowdiagramrepresentingthereportofadverseeventsrelatedtomedicaldevicesthroughhelpline.
TheworkflowfordeterminingthereportresponsiblefortheidentificationofadverseeventssignificantlyrelatedtomedicaldevicesisshownatFigure4.
Figure4.Medicaldevice-relatedadverseeventsidentificationflowchartusedatmedicaldeviceadverseeventmonitoringcentres(MDMC)
ReportHandlingandManagementInitially,thereportsarecollectedandanalysedattheNCC-MvPI,IPC,byapplyingthegloballyrecognizedscientificstandards/parameterstoensurethequalityofthereports.Inthesecondlevel,theseanalysedcasesareforwardedtothesubjectexpertgrouppanelforreview,andtechnicalinterpretationisdrawnconsideringboththeclinical,aswellastechnicalaspects.Inthethirdlevel,thesereportsareplacedbeforethecoretechnicalcommitteefortheconclusionsandrecommendations,andarefurtherforwardedtothenationalregulatoryauthorityforimplementationofthenecessaryactions(Figure4)[19].
DataGeneratedTheNCChascollectedthereportedadverseeventsandprovidedacomparisonoftheseriousadverseeventsreportedintheindexperiodfromJanuarytoDecemberduringtheyearsof2018,2019and2020.Intotal,NCChasreceived3187adverseevents,consistingof1986seriousand1201non-seriousevents.Outoftheseriousadverseeventsreported,23%werereportedin2018,37%in2019and40%in2020.Whencomparingthereporteddata,anincreaseof75%inseriousadverseeventreportingcouldbeobserved.Outoftheadverseeventsreported,73%ofthereportswerereceivedfromMAHs,23%fromMDMCsand4%fromAMCs[19].Thisconfirmsandhighlightstheimportanceofthemodalitiesdeveloped,astheyhavesignificantlyhelpedtoimprovethereportingofadverseeventsrelatedtomedicaldevices.
ConclusionThetoolsdevelopedforreportingmaystimulatethecommunicationbetweenmedicaldeviceusersandtheregulatoryauthoritiestocloselymonitormedicaldevicesafety.InordertogenerateproperregulatorydecisionsandtoensurethequalityandefficacyofthemedicaldevicesthatarebeingsoldanddistributedintheIndianmarket,MvPIhasshowntoprovidearobustandsustainablesystemforcollectingandreportingadverseeventsassociatedwithmedicaldevices.Thiswillhighlyencourageallthehealthcareprofessionals,MAHandthepublictoefficientlyreportadverseeventsassociatedwithmedicaldevices.